When Donald Trump and Robert F Kennedy Jr stood up at the press conference in September to tout leucovorin, a vitamin B derivative, as a treatment for autism, some neurodevelopmental doctors were shocked – and they braced themselves. There was little evidence to suggest the folinic acid helps with autism, yet there was an immediate flood of parents calling and scheduling visits to talk about the medication.
“The average parent who maybe wasn’t getting the right information said, ‘Well, to be good parents, we need to try this,’” said William Graf, a professor of pediatrics and neurology at Connecticut Children’s Medical Center. Outpatient leucovorin prescriptions for children ages five to 17 in the US rose by 71% in the weeks following the announcement, new research shows.
But on 10 March, the FDA approved leucovorin only for cerebral folate deficiency, in an apparent walk-back from officials’ statements about autism. The treatment seems to help treat “developmental delays with autistic features”, Marty Makary, commissioner of the US Food and Drug Administration (FDA), said in a statement – a reference to the ways cerebral folate deficiency, a very rare condition, can appear similar to autism.
Only months ago at the September press conference, Makary was much more explicit about folinic acid as the first FDA-recognized treatment for autism.
“Hundreds of thousands of kids, in my opinion, will benefit,” he said, stating that being autistic “may be entirely preventable”. The drug “may help 50 to 60% of kids with autism”, Makary claimed on C-SPAN. He also said on Becker’s Healthcare Podcast that “in the right population of children with autism, two-thirds of kids can see a clinical improvement and some a dramatic improvement in their autism symptoms”.
Other officials also spoke to the potential benefits of leucovorin for autism.
“This gives hope to the many parents with autistic children that it may be possible to improve their lives,” Trump said. Kennedy, the secretary of the US Department of Health and Human Services (HHS), said it was “an exciting therapy that may benefit large numbers of children who suffer from autism”.
All the specialists wondered if this meant that families should try it? Should they put their kid through a spinal tap to see if they had a deficiency? There was no information on dosage since there hadn’t been any kind of clinical trial.
Dr. Graf said “This is not a panacea. This is not a wonder drug that was out there but no one knew about it. It was just propagated from a government that, at the same time, doesn’t want to fund ACA, isn’t supporting research and is vaccine hesitant.” With the FDA approving the drug only for folate deficiency, “it’s almost like they’re backtracking now, they’re trying to get out of it”, Graf said.
The biggest study on leucovorin for autism – which only followed 77 children – was retracted in January after re-analyses of the data failed to find the same results. The only other studies have faced criticism for small sample sizes and improper blinding. The American Academy of Pediatrics (AAP) said in October that it does not recommend leucovorin for autistic children because of limited evidence.
You literally can’t believe anything the United States government says right now. And it’s going to take years to rebuild whatever trust there was before. Millions of families were given false hope by this and that’s just cruel.
Meanwhile, they’re blocking the most promising medical breakthrough in many moons, mRna research, because of some voodoo bullshit from the right wing fever swamps that has no scientific basis. More people will die needlessly.
Wake me up when this is over…
